SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1927-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

Product Classification:

Class II

Date Initiated: May 10, 2013

Date Posted: August 14, 2013

Recall Number: Z-1927-2013

Event ID: 65444

Reason for Recall:

Device design.

Status: Terminated

Product Quantity: 12 devices

Code Information:

Lot/Serial Numbers: 027104, 027105

Distribution Pattern:

Nationwide Distribution including Texas, Ohio, and Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated